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Item 1. Business

2024-01-16 compared with 2023-01-04 · 150 added, 276 removed, 226 unchanged (65% of the section changed)

Biosciences, Inc.

is a biotechnology company developing vaccines and therapies that are focused on critical unmet needs in oncology and

infectious disease.

Our vaccine programs include (i) the development of a preventative vaccine against triple negative breast cancer

(“TNBC”), the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the development of a preventative

vaccine against ovarian cancer.

Our therapeutics programs include (i) the development of a chimeric endocrine receptor T-cell therapy,

a novel form of chimeric antigen receptor T-cell (“CAR-T”) technology, initially focused on treating ovarian cancer, which

is being developed at our subsidiary, Certainty Therapeutics, Inc.

(“Certainty”), and (ii) the development of anti-viral

drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.

is a biotechnology company developing vaccines and therapies that are focused on critical unmet needs in oncology.

Our vaccine programs include (i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”),

the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the development of a preventative vaccine against

ovarian cancer.

Our therapeutics programs include (i) the development of a chimeric endocrine receptor T cell therapy, a novel form of

chimeric antigen receptor T cell (“CAR-T”) technology, initially focused on treating ovarian cancer, which is being developed

at our subsidiary, Certainty Therapeutics, Inc.

(“Certainty”), and (ii) until March 2023, the development of anti-viral drug

candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus.

hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic

Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.

agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.

this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast

cancer, focused specifically on TNBC.

cancer, focused initially on TNBC.

The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during

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Studies have shown that vaccinating against this protein prevents breast cancer in mice.

Food and Drug Administration’s (“FDA”) authorization to proceed with clinical trials in December 2020, in

October 2021, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine.

This study, which is being funded

Department of Defense grant, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”)

of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.

October 2021, following the U.S.

Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing

patients in a Phase 1 clinical trial of our breast cancer vaccine.

This study, which is being funded by a U.S.

Department of Defense

grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of

the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response.

The study is being conducted

at Cleveland Clinic and will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer

within the past three years and are currently tumor-free but at high risk for recurrence.

During the course of the study, participants

will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.

Initial indications

from preliminary analyses suggest that an immune response is being observed.

In December 2022, we announced that we had reached the MTD.

We are now expanding the MTD cohort and are vaccinating additional participants at that dose level.

Upon completion of vaccination and

follow-up tests of the expanded cohort, we will compile and analyze the data, and we anticipate presenting the complete immunological

data from the trial at a scientific conference or similar setting in the second calendar quarter of 2023.

at Cleveland Clinic.

The first segment of the study, Phase 1a, will consist of 18 to 24 patients who have completed treatment for early-stage,

triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.

that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years

after standard of care treatment.

During the course of the Phase 1a study, participants will receive three vaccinations, each two weeks

apart, and will be closely monitored for side effects and immune response.

In January 2023, the number of participants in each dose cohort

was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts.

In December 2023, we presented

the immunological data collected to date at the San Antonio Breast Cancer Symposium.

The data presented show that in the vaccinated women

who had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels.

We have begun vaccinating

participants in up to three additional dose cohorts at dose levels higher than the currently determined MTD and lower than the highest

dose where we observed dose limiting toxicity.

Further, we have commenced vaccination of participants in the second segment of the trial,

Phase 1b, that includes participants who have never had cancer, but carry certain genetic mutations such as BRCA1, BRCA2 or PALB2, that

indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy.

Finally, we are currently

enrolling participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease

following neoadjuvant chemo-immunotherapy and are currently undergoing treatment with pembrolizumab (Keytruda®).

November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide,

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vaccine technology.

This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers

which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).

In healthy tissue,

this protein regulates growth and development of egg-containing follicles in the ovary.

While expression of AMHR2-ED naturally and markedly

declines after menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.

at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

We entered into a joint

development agreement with Cleveland Clinic to advance this vaccine toward human clinical testing.

May 2021, Cleveland Clinic was granted an award for our ovarian cancer vaccine technology by the National Cancer Institute’s (“NCI”)

PREVENT program.

The NCI is a part of the National Institutes of Health.

The PREVENT program is a peer-reviewed agent development program

designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards

clinical trials.

The scientific and financial resources of the PREVENT program will be used for our ovarian cancer vaccine technology

to perform virtually all pre-clinical research and development, manufacturing and IND-enabling studies.

This work is being performed

at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the

Company, nor the transfer of any rights to the Company’s assets.

The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific

development milestones.

This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian

cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).

tissue, this protein regulates growth and development of egg-containing follicles in the ovary.

While expression of AMHR2-ED naturally

and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian

Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the National Cancer Institute’s

(“NCI”) PREVENT program.

The NCI is a part of the National Institutes of Health (“NIH”).

The PREVENT program

is a peer-reviewed agent development program designed to support pre-clinical development of innovative interventions and biomarkers

for cancer prevention and interception towards clinical trials.

The scientific and financial resources of the PREVENT program are being

used for our ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, manufacturing and Investigational

New Drug (“IND”) application enabling studies.

This work is being performed at NCI facilities, by NCI scientific staff and

with NCI financial resources and will require no material financial expenditures by the Company, nor the transfer of any rights of the

Company’s assets.

subsidiary, Certainty, is developing immuno-therapy drugs against cancer.

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to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent

biomedical research institute and a leading National Cancer Institute designated cancer research center, relating to Wistar’s chimeric

endocrine receptor targeted therapy technology.

We have initially focused on the development of a treatment for ovarian cancer, but we

also may pursue applications of the technology for the development of treatments for additional solid tumors.

The license agreement requires

Certainty to make certain cash and equity payments to Wistar upon achievement of specific development milestones.

With respect to Certainty’s

equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of

biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor

targeted therapy technology.

We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications

of the technology for the development of treatments for additional solid tumors.

The license agreement requires Certainty to make certain

cash and equity payments to Wistar upon achievement of specific development milestones.

With respect to Certainty’s equity obligations

to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty, such equity

stake subject to dilution by further funding of Certainty’s activities by the Company.

Due to such Company funding, Wistar’s

equity stake in Certainty was 4.6% as of October 31, 2023.

in collaboration with the H.

Lee Moffitt Cancer Center and Research Institute, Inc.

(“Moffitt”), is advancing toward human

clinical testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.

We received authorization

from the FDA in August 2021, to commence enrollment and treatment of patients in a Phase 1 clinical trial.

We began patient recruitment

for the trial in March 2022, and in August 2022, we treated the first patient in the trial.

The treatment appears to have been well-tolerated

by the patient, and we continue to monitor her condition.

The process of recruiting additional patients is ongoing.

This study is a dose-escalation

trial with two arms based on injection method—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients

with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T-cells.

The study is being

conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of chemotherapy.

The study is estimated

to be completed in two to four years depending on multiple factors including when maximum tolerated dose is reached, the rate of patient

recruitment, and how long we maintain the two different injection methods.

April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) to discover and ultimately develop anti-viral

drug candidates against COVID-19.

Through this collaboration, we utilized advanced computational methods, machine learning, and molecular

modeling techniques to perform in silico screening of over 1.2 billion compounds in chemical libraries (including publicly available

compounds and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt one of two key enzymes of SARS-CoV-2,

the virus that causes the disease COVID-19.

screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus,

including the virus’ main protease, M pro .

Several of these compounds were synthesized and tested in in vitro

biological assays.

Upon completion of these biological assays, we identified two of the most promising compounds and tested them in animal

In these animal studies, the two compounds were compared to Remdesivir, which at the time the assays were performed was the only

anti-viral drug authorized by the FDA for COVID-19.

The data showed that administration of the drugs to infected hamsters did not cause

any noticeable adverse effects, and monitoring of weight and general animal behavior demonstrated comparable efficacy between each of

our compounds and Remdesivir.

Based on this promising data in the animal study, we directed our team to proceed to the next stage of

drug development and we selected one of the compounds around which our team is performing combinatorial synthetic medicinal chemistry

to evaluate whether potency can be increased and pharmacokinetics optimized.

This work is ongoing.

May 2021, after completion of the aforementioned animal studies, OntoChem assigned its rights and obligations related to this collaboration

to MolGenie GmbH (“MolGenie”), a company spun-out from OntoChem focused on drug discovery and development.

As a result of

the MolGenie spin-out, there was no change in the personnel working on our project, and the assignment caused no interruptions to the

program’s development.

use of preventative vaccines is widespread throughout much of the developed world, we believe that there is and will continue to be a

need for effective treatments for COVID-19.

We believe that there are a number of factors that have limited the effectiveness, both in

the near and long term, of the vaccines currently in use, including, but not limited to, vaccine persistence, viral escape and perceptions

of long-term safety resulting in vaccine resistance.

Furthermore, there are currently new anti-viral treatments, such as Pfizer’s

Paxlovid, which is a combination therapy consisting of the protease-inhibitor nirmatrelvir and the antiretroviral ritonavir, that have

been authorized for use in the U.S.

As the main component of Pfizer’s treatment is a protease-inhibitor targeting M pro ,

it is most similar to our compounds, and we therefore conducted a head-to-head analysis via a Fluorescence Resonance Energy Transfer

(FRET) assay that tested the ability of the compounds to inhibit the function of M pro .

The results of this head-to-head in

vitro analysis suggested that our compounds may be five times more effective at inhibiting M pro than Pfizer’s nirmatrelvir.

the next several quarters, we expect the development of our breast and ovarian cancer vaccines, our COVID-19 therapeutic discovery program

and Certainty’s CAR-T technology to be the primary focus of the Company.

As part of our legacy operations, the Company remains

engaged in limited patent licensing activities regarding its liquid biopsy platform and in the area of encrypted audio/video conference

We do not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these

activities to require material financial resources or attention of senior management.

(“Moffitt”), has begun human clinical

testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.

After receiving authorization

from the FDA, we commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022.

in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose level as the first

patient, and the treatment appears to have been well-tolerated by all patients treated to date.

We anticipate that we will begin enrolling

the successive patient cohort, that we expect to give a three-times higher dose of cells, in the first calendar quarter of 2024.

study is a dose-escalation trial with two arms based on delivery method—intraperitoneal or intravenous—to determine the maximum

tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified

The study is being conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of

chemotherapy.

The study is estimated to be completed in two to four years depending on multiple factors including when maximum tolerated

dose is reached, the rate of patient enrollment, and how long we maintain the two different delivery methods.

April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) which was later assigned to MolGenie GmbH, a

company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates

against COVID-19.

Through this collaboration, we identified compounds that appeared to be effective in disrupting the main protease of

SARS-CoV-2, the virus that causes the disease COVID-19.

While our compounds have shown promise as an effective treatment, results of

animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may

be developed.

We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments

Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources

from more promising projects.

Therefore, in March 2023, we decided to pause further development of our COVID-19 therapeutic.

to prosecute our U.S.

patent applications of this technology and may decide to restart development at some time in the future.

the next several quarters, we expect the development of our vaccines and therapeutics to be the primary focus of the Company.

of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios.

not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require

material financial resources or attention of senior management.

the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from

the settlement of litigation.

We have not generated any revenue to date from our therapeutics or vaccine programs.

In addition, while

we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging

technologies.

We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near

Our strategy is to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that

have the resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines.

licensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from human

clinical trials.

the settlement of litigation (during the year ended October 31, 2023, we derived approximately $210,000 of revenue from these activities).

We have not generated any revenue to date from our vaccine or therapeutics programs.

In addition, while we pursue our vaccine and therapeutics

programs, we may also make investments in and form new companies to develop additional emerging technologies.

We do not expect to begin

generating revenue with respect to any of our current vaccine or therapy programs in the near term.

We hope to achieve a profitable outcome

by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,

market and sell our technologies as vaccines or therapeutics.

The eventual licensing of any of our technologies may take several years,

if it is to occur at all, and may depend on positive results from human clinical trials.

and Ovarian Cancer vaccines

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to American Cancer Society statistics, breast cancer accounts for over 30% of all female cancer cases, and 15% of cancer deaths in women.

It is estimated that in 2022, 288,000 new cases of breast cancer will be diagnosed in the U.S.

and 43,000 women will die from this disease.

Despite continuous advances made in the field of cancer research every year, invasive female breast cancer incidence rates have been

increasing by approximately 0.5% per year over the past 15 years.

It has been estimated that in 2023, 301,000 new cases of breast cancer would be diagnosed in the U.S.

and 43,000 women would die from

this disease.

Despite continuous advances made in the field of cancer research every year, invasive female breast cancer incidence rates

have been increasing by approximately 0.5% per year over the past 15 years.

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

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who have a possibility of developing the disease.

in the U.S., 288,000 women are estimated to be diagnosed with breast cancer this year, there are approximately 82 million women age 40

in the U.S., 301,000 women were estimated to be diagnosed with breast cancer in 2023, there are approximately 82 million women age 40

and over—the time in life when women face an increased risk of developing breast cancer.

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Ovarian Cancer Market

to American Cancer Society statistics, ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer

deaths in women due to the disease’s low survival rate.

It is estimated that in 2022, 20,000 new cases of ovarian cancer will

be diagnosed and 13,000 American women will die from this disease.

Despite continuous advances made in the field of cancer research

every year, we believe there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian

cancer patients is 49%.

However, ovarian cancer survival varies substantially by age, with the overall five-year survival rate for

women 65 and older of only 33%.

to American Cancer Society statistics, ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer deaths

in women due to the disease’s low survival rate.

It has been estimated that in 2023, 20,000 new cases of ovarian cancer would be

diagnosed and 13,000 American women would die from this disease.

Despite continuous advances made in the field of cancer research every

year, we believe there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian cancer patients

However, ovarian cancer survival varies substantially by age, with the overall five-year survival rate for women 65 and older

market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.

the U.S., 20,000 women are estimated to be diagnosed with ovarian cancer this year, there are approximately 41 million women age 60 and

the U.S., 20,000 women were estimated to be diagnosed with ovarian cancer in 2023, there are approximately 41 million women age 60 and

over—the time in life when women face an increased risk of developing ovarian cancer.

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The following summarizes the results of these studies:

treated mice showed any signs of pain/stress, difficulty breathing or increased respiratory

rate, reduced movement, reduced grooming or feeding, dehydration, anorexia or any other sign

treated mice showed any signs of pain/stress, difficulty breathing or increased respiratory rate, reduced movement, reduced grooming

or feeding, dehydration, anorexia or any other sign of distress.

Control mice also did not show any distress.

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Control mice also did not show any weight loss.

cohort of treated mice also had blood drawn periodically for measurement of markers for liver

function (AST-Aspartate transaminase/ALT-Alanine transaminase), kidney function (creatinine),

and metabolic function (glucose).

No abnormal values were observed, as was the case for control

IL-6 (interleukin-6) increased in the treated mice, as well as mice treated with control

This indicated that the T-cells were inducing the expected inflammatory response.

● Histological

analysis of the ovaries showed that 60% of the treated mice had significant reduction in

ovarian mass, while the control mice exhibited no reduction.

This observation confirms that

the CAR-T was successfully attacking the ovaries, as we hoped and expected.

cohort of treated mice also had blood drawn periodically for measurement of markers for liver function (AST-Aspartate transaminase/ALT-Alanine

transaminase), kidney function (creatinine), and metabolic function (glucose).

No abnormal values were observed, as was the case

for control mice.

IL-6 (interleukin-6) increased in the treated mice, as well as mice treated with control T cells.

This indicated that the T cells

were inducing the expected inflammatory response.

analysis of the ovaries showed that 60% of the treated mice had significant reduction in ovarian mass, while the control mice exhibited

no reduction.

This observation confirms that the CAR-T was successfully attacking the ovaries, as we hoped and expected.

these results are positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization.

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resources and infrastructure in place to manufacture, market and sell our technology as a cancer treatment.

August 2022, we treated the first patient in the trial.

The treatment appears to have been well-tolerated by the patient, and we continue

to monitor her condition.

The process of recruiting additional patients is ongoing.

This study is a dose-escalation trial with two arms

based on injection method—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent

epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T-cells.

The study is being conducted at

Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of chemotherapy.

The study is estimated to be

completed in two to four years depending on multiple factors including when maximum tolerated dose is reached, the rate of patient recruitment,

and how long we maintain the two different injection methods.

believe that our CAR-T technology may be used as an effective treatment against multiple solid tumor types, however, we have initially

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cases, but nearly 5% of cancer deaths in women due to the disease’s low survival rate.

It is estimated that in 2022, approximately

20,000 new cases of ovarian cancer will be diagnosed and 13,000 American women will die from this disease.

It has been estimated that in 2023, approximately

20,000 new cases of ovarian cancer would be diagnosed and 13,000 American women would die from this disease.

Despite continuous advances

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in our competitors establishing a strong market position before we are able to enter the market.

disease 2019 (“COVID-19”) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-2”).

The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread globally,

resulting in the ongoing coronavirus pandemic.

SARS-CoV-2 is highly infectious, and while in the majority of cases results in mild symptoms,

in many cases the symptoms progress to viral pneumonia and multi-organ failure.

are currently few broadly effective treatment options.

Further, nearly all treatments currently in use or in clinical trials were originally

developed for other indications, and were not designed specifically against SARS-CoV-2, and therefore may have limited effectiveness.

We believe that newly designed drugs that are purposefully developed to specifically target SARS-CoV-2, enabled by recent studies of

the molecular biology of the virus, will have the potential to be far more effective than repurposing existing drugs.

April 2020, we entered into a collaboration agreement with OntoChem, who subsequently assigned its rights and obligations under the collaboration

agreement to MolGenie, for the purpose of discovering and ultimately developing anti-viral drug candidates for COVID-19.

Our collaboration

has primarily focused on the virus’ main protease (“M pro ”), which is an enzyme of the virus that severs

a large poly-peptide into functional proteins that enable the virus to replicate in a human host.

Our program has focused on identifying

molecules that inhibit the function of this enzyme, and potentially stop or slow the virus’ ability to replicate and cause disease.

Since this protease does not have human analogs, potential inhibitors may not affect any human proteins and therefore toxic side effects

may be minimized.

our collaboration, we utilized advanced computational methods, machine learning and molecular modeling techniques to perform in silico

screening of over 1.2 billion compounds in OntoChem’s chemistry and gene ontology database (including publicly available compounds

and OntoChem’s proprietary libraries) to evaluate if any of these compounds could disrupt M pro and to evaluate the molecules’

potential side effects, as well as their drug-like characteristics.

This screening process resulted in identifying a large number of

compounds that could potentially be safe and effective against COVID-19.

screening process resulted in the identification of multiple compounds that could potentially disrupt critical enzymes of the virus.

Several of these compounds were synthesized and tested in in vitro biological assays.

Upon completion of these biological assays,

we identified two of the most promising compounds and tested them in animal models.

In these animal studies, the two compounds were compared

to Remdesivir, which at the time the assays were performed was the only anti-viral drug authorized by the FDA for COVID-19.

showed that administration of the drugs to infected hamsters did not cause any noticeable adverse effects, and monitoring of weight and

general animal behavior demonstrated comparable efficacy between each of our compounds and Remdesivir.

Based on this promising data in

the animal study, we directed our collaboration partners to proceed to the next stage of drug development and we selected one of the

compounds around which our partners and other third-party service providers are performing combinatorial synthetic medicinal chemistry

to evaluate whether potency can be increased and pharmacokinetics optimized.

This work is ongoing.

SARS-CoV-2 has continued to mutate over the course of the pandemic, we have performed genomic variant analysis to determine whether our

compounds may be effective against multiple variants.

To date, the results of such analyses have shown that either no significant mutations

have been found in or near the active site of the M pro enzyme or any known mutations do not change the function of the enzyme,

and therefore we believe that our compounds should be effective against multiple variants, including the Omicron variant and its subvariants,

though there is no assurance that this will be the case.

Centers for Disease Control and Prevention (“CDC”) data, as of the date of this Report, in the U.S., there have

been over 100 million cases of COVID-19 and nearly 1.1 million deaths.

According to World Health Organization (“WHO”)

data, globally, there have been 650 million cases and over 6.6 million people have died.

While the infection and death rates have

reduced significantly since the peak of the pandemic, according to the most recent CDC data, in the U.S.

the current 7-day average

of weekly new cases is approximately 65,000, the 7-day average daily hospitalizations is approximately 5,000 and the 7-day average

daily deaths is over 400.

there are few broadly effective treatment options for COVID-19.

Further, the most common treatments that are currently being employed,

were originally developed for other indications, and were not designed specifically against SARS-CoV-2, and therefore may have limited

effectiveness.

In addition, the orally-available anti-viral treatment developed by Pfizer has limitations as it requires a combination

therapy with an antiretroviral drug commonly used to treat HIV and is known to have challenging side effects.

market for orally delivered COVID-19 treatments that are effective against multiple variants of the virus, with limited side effects

would be significant.

in the COVID-19 treatment and prevention market is fierce, with hundreds of therapies and vaccines currently in development.

currently a number of preventative vaccines that have received regulatory approvals globally.

While these vaccines have been effective

in reducing the spread of COVID-19, there remain challenges regarding persistence and viral escape as well as the resistance to vaccination

by a significant portion of the population and also the difficulty in vaccinating and boosting the world population.

Further, the current

leading treatment is the orally-available combination protease-inhibitor-antiretroviral Paxlovid, developed by Pfizer.

Any product candidates

that we successfully develop and commercialize will have to compete with existing therapies and vaccines and new therapies and vaccines

that may become available in the future.

While we believe that our proprietary compounds for treating COVID-19 and scientific expertise

in the field of synthetic chemistry provide us with competitive advantages, we face potential competition from various sources, including

larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and

public and private research institutions.

of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources

than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory

approvals of treatments and commercializing those treatments.

Accordingly, our competitors may be more successful than us in obtaining

approval for treatments and achieving widespread market acceptance.

Our competitors’ treatments may be more effective, or more

effectively marketed and sold, than any treatment we may commercialize and may render our treatments obsolete or non-competitive before

we can recover the expenses of developing and commercializing any of our treatments.

and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller

number of our competitors.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel

and establishing clinical study sites and subject registration for clinical studies, as well as in acquiring technologies complementary

to, or necessary for, our program.

Smaller or early-stage companies may also prove to be significant competitors, particularly through

collaborative arrangements with large and established companies.

anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available.

We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience

of administration and delivery, price and the availability of reimbursement from government and other third-party payers.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors

also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result

in our competitors establishing a strong market position before we are able to enter the market.

of October 31, 2023, we had five employees, four full-time and one part time, working for our Company and subsidiaries.

we work with research teams at Moffitt, Cleveland Clinic, and MolGenie, as well as their subcontractors, to develop each of our projects.

we work with research teams at Moffitt and Cleveland Clinic, as well as their and our subcontractors, to develop each of our projects.

risk factors described below are a summary of the principal risk factors associated with an investment in us.

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therapeutics and vaccines that we are developing are novel and present significant challenges to successfully reaching market.

pre-clinical testing of our product candidates has been positive, we may experience unfavorable results and unforeseen delays once

we commence human clinical trials.

pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable

results once we collect statistically significant data from human clinical trials.

are dependent on third parties to conduct our pre-clinical and clinical trials.

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Related to our Common Stock

issuance or sale of shares in the future, including in connection with our current “at the market offering” program,

to raise money or for strategic purposes could reduce the market price of our common stock.

issuance or sale of shares in the future, including in connection with our current at-the-market offering program, to raise money

or for strategic purposes could reduce the market price of our common stock.

have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.

and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage

ownership interest and may also result in downward pressure on the price of our common stock.

Related to the COVID-19 Pandemic

business activities, including our clinical trials, may be delayed or otherwise adversely affected by the ongoing COVID-19 pandemic.

and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute stockholders’

percentage ownership interest and may also result in downward pressure on the price of our common stock.

were incorporated on November 5, 1982 under the laws of the State of Delaware.

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Expressway, San Jose, California 95118, our telephone number is (408) 708-9808 and our Internet website address is www.anixa.com .

make available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current

We make available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current

reports on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or

4 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business